On March 26th, 2018, the long-awaited Advanced Notice of Public Rule Making (ANPRM) in regards to premium cigars was published by the U.S. Food and Drug Administration (FDA). It’s a document that paints the picture in terms of what the FDA is thinking – namely how or if it should regulate premium cigars. As a part of that period, there is a public comment period to provide feedback into the FDA’s way of thinking. At press time (April 8th), a total of 457 comments have been submitted. Based on what I have currently seen in the comments, my concern is the industry as a whole needs to deliver a stronger message to the FDA.

First up, we need to understand that the FDA believes that what it is doing is in the best interest of public health. Cigar enthusiasts may not agree with that statement, but it’s a fact. Whether jobs are eliminated or it restricts your liberties is of less of a concern to the FDA than the mantra of protecting public health. As we have heard, the new FDA Commissioner, Dr. Scott Gottlieb is (saying he is) very much taking a science-based approach.  It is primarily scientific data that the FDA is looking for and this is documented in the ANPRM.

FDA stated that it would solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars and consider the appropriate regulatory status of premium cigars.

The FDA also stated that they feel they have not received this information in the past.

 We received numerous comments on the deeming proposed rule with respect to premium cigars, both in favor of and against regulating these products. However, the comments against regulation provided little data to support the opinions expressed and, where studies were submitted, provided little information about the studies cited.

When I took a look at the 457 comments submitted thus far, I have four generalizations from what I’ve seen (these are paraphrased)

  1. There are still a lot of comments along the lines of “Premium Cigars should not be regulated. Keep your hands off my cigars!” (Personal Liberties)
  2. There are still a lot of comments like “the Deeming Regulations will wipe out the premium cigar industry in the United States.” (Business Impacts)
  3. There is a lack of response from the larger boutiques, medium-sized companies, and large companies.
  4. There are facts submitted in the comments that are not substantiated by data or studies.

What concerns me as a cigar enthusiast who would love to see the FDA regulations go away is that the feedback submitted is not what the FDA is looking for. It’s too much focused on a commentary on personal liberties and business impacts.  I’m not trying to discourage feedback on these topics, but this simply isn’t what the FDA is looking for.

Right now it’s #3 on my generalizations that concerns me the most. I applaud consumer feedback and it should be no surprise that many of the comments focus on personal liberties and business impacts.  A consumer is not going to be in a position to deliver the science-based feedback the FDA is looking for, yet we shouldn’t discourage participation in the feedback process. However, I would expect the cigar companies who own the brands, and in some cases own the factories, to be stepping up here. My glance at the comments is that very few have done this, and many of the comments from the stakeholders have still focused on personal liberty and business impacts. In my opinion, the letter referenced at the following link is the best example of what the FDA is looking for in terms of feedback.

There are other comments that attempt to give the scientific data, but often there isn’t even a hyperlink or attachment to the case study. Keep in mind, the FDA probably isn’t going to google what is being referenced. In some cases things that are facts are being mistaken for opinion. Saying “18-year-olds don’t smoke cigars” is not as effective as backing it up with a study showing this.

The bottom line is that all stakeholders in the cigar industry need to step up here and provide real research and deliver feedback. Sending a social media link asking consumers to help is fine, but if that is all that a cigar company is doing – that is not enough. As for the Trade Associations, IPCPR, CRA, and CAA have done their due diligence before, and they will do their due diligence again. They will most likely take full advantage of the 90-day window to get the facts and data together, so my preceding comments are not directed at them. In the meantime, my hope is each stakeholder is also using the 90-day window to gather the facts the FDA is looking for. The comment period for the ANPRM on premium cigars is scheduled to close on June 25, 2018.

There are two other ANPRMs and both still have impacts premium cigars. At press time, there have only been 19 comments published on the ANPRM related to nicotine levels. This is a surprisingly low number considering this was the first of the ANPRMs and it has widespread consequences for not just the cigar industry, but the tobacco industry as a whole. The other ANPRM is related to flavored tobacco. The flavored tobacco ANPRM has been the most active with 1623 comments. The comment period for the ANPRM on nicotine levels is scheduled to close on June 14, 2018. Meanwhile, the comment period for the ANPRM on flavored tobacco is scheduled to close on June 19, 2018.